Exudative Macular Degeneration Clinical Trial
— TAPASOfficial title:
Intravitreal Tissue Plasminogen Activator And Perfluoropropane for Neovascular Age-related Macular Degeneration With Associated Submacular Haemorrhage: a Multi-centre, Randomized, Double-masked, Sham-controlled, Factorial, Feasibility Study
Verified date | February 2020 |
Source | King's College Hospital NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will recruit patients who have recently had a submacular haemorrhage (bleed under
the part of the retina responsible for detailed vision), as a complication of wet age-related
macular degeneration (wet AMD). Wet AMD is a very common disease where abnormal blood vessels
form under the retina and leak, causing a significant reduction in vision.
The study will investigate treatment of the bleed with various combinations of the two drugs:
tissue plasminogen activator (tPA) - designed to dissolve the blood clot; and
perfluoropropane (C3F8) - designed to shift the blood clot away from the central part of the
retina (the macula). tPA is a commonly used 'clot-buster' drug for the treatment of stroke.
C3F8 is a gas commonly used in eye surgery. Patients recruited will be divided into four
groups: control group that receive none of the above drugs; one group that receives only tPA;
one group that receives only C3F8; and one group that receives both.
All patients will receive the current gold standard treatment for wet AMD, ranibizumab
(Lucentis®).
The aim of the study is to improve vision in a condition, which left untreated, would cause
severe visual loss.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion criteria: - Adults of either sex aged 50 years and older; - SMH associated with treatment-naive or previously treated wet AMD, including retinal angiomatous proliferation (RAP) and idiopathic polypoidal choroidal vasculopathy (IPCV); - SMH of at least 1 disc area, involving the fovea, and of sufficient density to obscure RPE detail; - Written informed consent to participate in the study.Only one eye will be eligible for inclusion in this study. Exclusion criteria: - SMH that is known to have been present for greater than 2 weeks duration, as evidenced by history, pre-trial documentation, or fundus appearance; - Presence of significant vitreous haemorrhage precluding accurate retinal assessment in the study eye; - Diabetic maculopathy in the study eye; - Visually significant cataract in the study eye; - Amblyopia in the study eye; - Presence of other ocular disease causing concurrent vision loss in the study eye; - Advanced glaucoma in the study eye (cup-to-disc ratio greater than 0.8); - Pregnant and or lactating women; - Women of childbearing potential including those who are not sterilised or at least one year post menopausal; - Participation in a clinical interventional trial in the preceding 6 months; - Documented evidence of a visual acuity less than 25 ETDRS letters at three consecutive visits in the study eye, prior to the onset of submacular haemorrhage; - Participants who are known to have been ineligible for NICE approved ranibizumab therapy prior to the development of the SMH; - Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab, bevacizumab or aflibercept; - Patients who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol, including posturing requirements. - Patients who show insufficient understanding of the clinical trial or treatment options. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hull & East Yorkshire Hospital NHS Trust | Hull | |
United Kingdom | King's College Hospital NHS Foundation Trust | London | |
United Kingdom | Maidstone Hospital | Maidstone | Kent |
United Kingdom | Southend University Hospital NHS Foundation Trust | Southend | |
United Kingdom | Sunderland Eye Infimary | Sunderland | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean ETDRS visual acuity | 3 months | ||
Secondary | Mean ETDRS visual acuity | 1 and 12 months | ||
Secondary | Percentage patients 15 letters or greater improvement in ETDRS visual acuity | 12 months | ||
Secondary | Percentage patients 0 letters or greater improvement in ETDRS visual acuity | 12 months | ||
Secondary | Percentage patients 15 letters or greater loss in ETDRS visual acuity | 12 months | ||
Secondary | Mean total area of macular haemorrhage on colour fundus photography | 1, 3 and 6 months | ||
Secondary | Greatest linear dimension of macular haemorrhage on colour fundus photography | 1, 3 and 6 months | ||
Secondary | Presence of subfoveal blood on colour fundus photography | 1 month |
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